Renal TransplantationPhase 3TAXINCT00682292
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk
A Phase 3 study testing Thymoglobulin (ATG) and Daclizumab in people with Renal Transplantation, run by University Hospital, Lille at 1 site in France.
Trial summary
To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Thymoglobulin (ATG) and Daclizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- May 2001to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Third or fourth renal graft or
- Current anti-HLA antibodies above or equal to 30% at the last evaluation or
- Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
- A second graft if the first was lost within 2 years because of rejection.
- Patients who gave their informed consent and are able to understand the scope of the study
Who cannot join
- Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
- Transplantation from a non-heart beating donor
- Transplantation of two kidneys from the same donor
- Patients with generalized infection at the time of transplantation
- Women in child-bearing age who do not plan to use efficient contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.
To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.
Read the detailed description
The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year.
Eligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.
- Conditions
- Renal Transplantation
- Being tested
- Thymoglobulin (ATG), Daclizumab
- Keywords
- Renal transplantation, Immunisation, Acute rejection, Induction therapy, Thymoglobulin, Daclizumab, Rejection in sensitized renal transplant recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymoglobulin (ATG)Drug
Also called Thymoglobulin, Genzyme
Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation
DaclizumabDrug
Also called Zenapax, Roche
Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation
| Study group | Role | What they receive |
|---|---|---|
| 1, ATG | Active comparator | Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids Receives: Drug: Thymoglobulin (ATG) |
| 2, Daclizumab | Active comparator | Dacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids Receives: Drug: Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-proven acute allograft rejection during the first post-transplant year
Measured: acute rejection proved by graft biopsy
Secondary outcomes (9)
Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.
Measured: graft dysfunction
Proportion of patients who experienced more than one episode of acute allograft rejection
Measured: graft dysfunction, biopsies
Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)
Measured: number of anti-lymphocyte treatment required for acute rejection episodes
Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm
Measured: graft dysfunction and biopsies
Banff grade of the first rejection episode
Measured: graft biopsy
Incidence of adverse events in the two treatment arms at 1 year
Measured: number of adverse events reported by the investigators
Incidence of delayed graft function
Measured: number of patient who required hemodialysis during the first week post transplantation
Graft function at 1 year
Measured: serum creatinine and estimated glomerular filtration rate
Graft and patient survival at 1 year
Measured: number of graft failures and/or deaths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMay 2001
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital
- Investigators
- Christian Noël, MD, PhD, Principal investigator, University Hospital of Lille, FranceDaniel Abramowicz, MD, PhD, Principal investigator, Erasme Hospital, Bruxelles, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682292
- Sponsor's protocol ID
- UHLillle
- Other IDs
- CRG020600038
- Acronym
- TAXI
- Status last verified
- Feb 2004
- First submitted
- 20 May 2008
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.
- ClinicalTrials.gov ID
- NCT00682292
- Acronym / sponsor ID
- TAXI / UHLillle
- Conditions
- Renal Transplantation
- Keywords
- Renal transplantation, Immunisation, Acute rejection, Induction therapy, Thymoglobulin, Daclizumab, Rejection in sensitized renal transplant recipients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Erasme University Hospital
- Study start
- May 2001
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.
Detailed description
The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year.
Eligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, ATG | Active comparator | Drug: Thymoglobulin (ATG)Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids |
| 2, Daclizumab | Active comparator | Drug: DaclizumabDacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Third or fourth renal graft or
- Current anti-HLA antibodies above or equal to 30% at the last evaluation or
- Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
- A second graft if the first was lost within 2 years because of rejection.
- Patients who gave their informed consent and are able to understand the scope of the study
Key exclusion criteria (5 listed)
- Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
- Transplantation from a non-heart beating donor
- Transplantation of two kidneys from the same donor
- Patients with generalized infection at the time of transplantation
- Women in child-bearing age who do not plan to use efficient contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymoglobulin (ATG)Also: Thymoglobulin, GenzymeThymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation | Drug | 1, ATG |
| DaclizumabAlso: Zenapax, RocheDaclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation | Drug | 2, Daclizumab |
Primary outcome
Incidence of biopsy-proven acute allograft rejection during the first post-transplant year
Time frame: acute rejection proved by graft biopsy
9 secondary outcomes
Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.
Time frame: graft dysfunction
Proportion of patients who experienced more than one episode of acute allograft rejection
Time frame: graft dysfunction, biopsies
Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)
Time frame: number of anti-lymphocyte treatment required for acute rejection episodes
Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm
Time frame: graft dysfunction and biopsies
Banff grade of the first rejection episode
Time frame: graft biopsy
Incidence of adverse events in the two treatment arms at 1 year
Time frame: number of adverse events reported by the investigators
Incidence of delayed graft function
Time frame: number of patient who required hemodialysis during the first week post transplantation
Graft function at 1 year
Time frame: serum creatinine and estimated glomerular filtration rate
Graft and patient survival at 1 year
Time frame: number of graft failures and/or deaths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Noël, MD, PhD principal investigator
University Hospital of Lille, France
Daniel Abramowicz, MD, PhD principal investigator
Erasme Hospital, Bruxelles, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymoglobulin (ATG) and Daclizumab in people with Renal Transplantation, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of biopsy-proven acute allograft rejection during the first post-transplant year (time frame: acute rejection proved by graft biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.